Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease

Plasma Ropivacaine Concentrations After Peripheral Nerve Block in Patients With Severe Renal Dysfunction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03666845

Enrollment

Registered

2018-09-12

Start date

2019-10-01

Completion date

2023-12-28

Last updated

2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthetic Drug Adverse Reaction, Regional Anesthesia Morbidity

Brief summary

This prospective observational study aimed to examine the pharmacokinetics of ropivacaine in patients with chronic kidney disease after sciatic nerve block. Sciatic nerve block for foot and ankle surgery will be performed using ropivacaine under ultrasound-guidance, and arterial blood test will be taken for total plasma ropivacaine concentration at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.

Interventions

PROCEDURESciatic nerve block

Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients scheduled for foot and ankle surgery * Patients with chronic kidney disease (glomerular filtration rate \< 60 ml/min/1.73m2) (changed from 30 ml/min/1.73m2 to facilitate patient recruitment) * Patients who are thought to be clinically helpful to receive sciatic nerve block rather than general anesthesia because of comorbidities such as cardiopulmonary dysfunction and cerebral dysfunction

Exclusion criteria

* Patients who need to renal replacement therapy, such as hemodialysis * Patients with liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L) * Patients with allergic disease * Patients with previous history of drug allery * Patients with chronic pain persisting 3 months

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentration of unbound ropivacaine	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block	whether the unbound plasma concentration of ropivacaine was maintained under 0.56 mcg/ml that was determined as toxic level in a previous study.

Secondary

Measure	Time frame	Description
Plasma concentration of 3-OH-ropivacaine	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block	metabolite of ropivacaine
Plasma concentration of pipecoloxylidide	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block	metabolite of ropivacaine
Postoperative pain score	2, 6, 24 hours after sciatic nerve block	11-point numeric rating scale ranging from '0' representing one extreme (e.g. extremely dissatisfied) to '10' representing the other extreme (e.g. extremely satisfied)
Local anesthetic systemic toxicity	2, 6, 24 hours after sciatic nerve block	numbness of the tongue, twitching, convulsion, dysarrhythmia, coma

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026